“The fact that we have a technology where the outcomes in women are equal to men is important,” said Roberta C. Bogaev, M.D., lead author of the study and medical director of heart failure and cardiac transplantation at the Texas Heart Institute in Houston. “Historically, because of their size, such devices have been unavailable to women of small stature. Now that we have a pump about the size of a D battery, it will allow us to expand mechanical circulatory support options to more women.”

The device is an implantable left ventricular assist device (LVAD) that supports the heart for patients with severe congestive heart failure and minimal medical options. It’s powered by a battery-run unit worn outside the body. The phase II study participants received the LVAD as a “bridge” to keep them alive until a donor heart became available. The trial involved 231 patients with advanced heart failure, 52 (23 percent) of them women.

Some study participants — six at the Texas Heart Institute alone — recovered sufficient pumping power to have the device removed and did not require a transplant operation. This can happen when heart failure patients are treated with a ventricular assist device and have a potentially reversible cause of the heart failure.

For the 194 patients with six-month follow-up data, survival was almost the same for both genders — 79.5 percent for women and 80.6 percent for men — among those who had undergone a heart transplant, had their LVAD removed after regaining ventricular function, or remained on the device.

Six patients, 3.3 percent women and 2.2 percent men, experienced strokes within two days after their surgery. Twelve patients (13.6 percent women and 5 percent men) suffered strokes more than two days after surgery. “Since this is a small number of patients, we will need to continue to follow patients with this device to determine if this is a significant finding between men and women,” Bogaev said.